The Weekly Pulse | 17th – 21st April | EU Machinery Products Regulation & More
What’s HOT in our Regulatory World
What are our clients looking at?
This week’s trending sources in C2P
- EU: Ecodesign Requirements for Off Mode, Standby Mode, and Networked Standby Energy Consumption of Electrical and Electronic Household and Office Equipment, Regulation (EU) 2023/826
- Compliance and Risks: Packaging Labelling Legislation in Europe: A Regulatory Update, White Paper, April 2023
- Compliance and Risks: Chemicals Quarterly – Q1 Regulatory Update 2023, Webinar Presentation, April 2023
What is our Content Team talking about?
EU Machinery Products: Parliament adopts its position on proposed regulation at first reading – Joyce Costello
The Parliament is recommending the following changes, among others, be made to the draft:
- Article 2(2): the Regulation would not apply to ordinary office machinery in so far as it falls within the scope of application of Directive 2014/35/EU or Directive 2014/53/EU. However additive printing machinery for producing three-dimensional products should be excluded from the foregoing, such that it would come within the scope of the Regulation;
- Article 3: supplement the proposal with the following definitions:
–‘safety function’ means a function that serves to fulfil a protective measure designed to eliminate, or, if that is not possible, to reduce, a risk, which, if it fails, could result in an increase of that risk.
–‘essential health and safety requirements’ means the mandatory provisions, set out in Annex III, relating to the design and construction of products within the scope of this Regulation to ensure a high level of protection of the health and safety of persons, and, where appropriate, domestic animals and property, and, where applicable, of the environment
–‘lifetime’ means the period from the moment that machinery or a related product is placed on the market or put into service until the moment that it is discarded, including the effective time when the machinery or related product is capable of being used and the phases of transport, assembly, dismantling, disabling, scrapping or other physical or digital modifications foreseen by the manufacturer;
–‘source code’ means the currently installed version of the software of a product within the scope of this Regulation, written in a programming language so that it is unambiguous and understandable to humans;
–‘professional user’ means a natural person who uses or operates machinery or a related product in the course of his or her professional activity or work.
- Articles 5-6: removal of ‘high-risk machinery products’ from the text and replace with “categories of machinery products subject to a specific conformity assessment procedure”. Annex I would comprise of two parts under its recommendation, A and B, with the products posing less risk included in Part B. Part B-listed machinery products would not need third-party conformity assessment (i.e., internal production control may be used as a conformity assessment.
- Article 10: Parliament is advocating the possibility of providing the instructions for use and the information set out in Annex III in a digital format. When the instructions for use are provided in digital format, the manufacturer would be required to -mark on the machinery or related product, or, where that is not possible, on its packaging or in an accompanying document, how to access the digital instructions.
-present them in a format that makes it possible for the user to print and download the instructions for use and save them on an electronic device so that he or she can access them at all times, in particular during a breakdown of the machinery or related product; this requirement also applies where the instructions for use are embedded in the software of the machinery or related product;
-make them accessible online during the expected lifetime of the machinery or related product and for at least 10 years after the placing on the market of the machinery or related product.
-in the case of machinery or a related product intended for non-professional users or that can, under reasonably foreseeable conditions, be used by non-professional users, even if not intended for them, provide, in paper format, the safety information that is essential for putting the machinery or related product into service and for using it in a safe way.
- Article 10: digital EU Declarations of Incorporation shall be made accessible online for at least 10 years after the placing on the market of the partly completed machinery. Partly completed machinery must be accompanied by the EU Declaration of Incorporation set out (Annex V, Part B) or, alternatively, manufacturers shall provide the internet address or machine readable code where that EU Declaration of Incorporation can be accessed in the assembly instructions.
- Article 10: digital EU Declarations of Conformity should be made accessible online for the expected lifetime of the machinery or related product and in any event for at least 10 years after the placing on the market or the putting into service of the machinery or related product. Manufacturers shall provide the internet address or machine-readable code where that EU Declaration of Conformity can be accessed in the instructions for use and the information set out in Annex III.
Parliament is seeking a 12-month deferral of the date of application (from 30 to 42 months after date of publication).
The Council may:
- decide to accept the Parliament’s position: in such a case the legislative act is adopted
- amend the Parliament’s position: the proposal is returned to the Parliament for a second reading.
What are our Knowledge Partners talking about?
European Due Diligence Increasing as Parliament Approves New Deforestation Regulation – Cooley
On 19 April 2023, the European Parliament formally approved a new European Union Deforestation Regulation on commodities and products associated with deforestation and forest degradation. The new Deforestation Regulation will impact companies selling products or packaging in or exporting them outside the EU if they contain certain commodities, including wood and rubber. The text that has been approved by the Parliament is unlikely to change before it becomes law.
Below, we’ve explained the main requirements of the Deforestation Regulation.
The European Commission proposed the Deforestation Regulation in 2021 to address deforestation and forest degradation in Europe and globally. It has now been agreed upon by the Council of the EU and the Parliament, and formally approved by the Parliament. The Deforestation Regulation will replace the existing EU Timber Regulation 995/2010.
To whom and what does it apply?
The Deforestation Regulation will apply to any person or company marketing specific products in the EU or exporting them from the EU if the products contain, have been fed with or have been made using any of the following commodities:
- Palm oil
Examples of such products include wood packaging (such as cases, boxes and crates), tableware, kitchenware and furniture; clothing and clothing accessories made with vulcanized rubber and articles of hard rubber; and printed books, newspapers, pictures and other printing industry products, such as leaflets and brochures.
What is it about?
The Deforestation Regulation will introduce, among others, the following requirements:
- Operators are banned from placing on the EU market and exporting from the EU products containing, fed with or made using the relevant commodities that:
-Are not deforestation-free;
-Have not been produced in accordance with the relevant legislation of the country of production;
-Are not covered by a due diligence statement.
- Operators must carry out due diligence for in-scope products and commodities to determine whether they are deforestation-free and have been produced in accordance with relevant legislation in the country of production.
- Operators must submit a due diligence statement to the competent national authorities before placing the products on the EU market or exporting them out of the EU.
- Competent authorities in Member States can ask operators to take corrective measures, including preventing the sale or distribution in the EU of relevant commodities and products; product withdrawal, recall and/or destruction; or measures requiring them to donate to charitable or public interest entities.
- Competent authorities also can impose sanctions, including fines, confiscation of products and revenues, and temporary prohibition from placing on the EU market or exporting from the EU in-scope products.
- Third parties (e.g., nongovernmental organizations, competitors and consumers) can submit substantiated concerns to the competent authorities when they believe that operators do not comply with the Regulation, and the competent authorities will be required to assess the concerns.
What is the anticipated timeline?
The Parliament approved the agreed text of the Deforestation Regulation at its plenary session on 19 April, 2023. The text now will pass to the EU Council for formal approval (usually a rubber-stamping exercise) and then will be published in the Official Journal of the European Union (OJEU).
The Deforestation Regulation will enter into force 20 days after it is published in the OJEU, and the obligations set out in the Regulation will be enforceable 18 months later. We anticipate that the requirements will become applicable by Q1 2025. Microenterprises and small enterprises will have a longer period of 24 months to comply with the new rules.
Why does it matter?
The Deforestation Regulation will have a significant impact on businesses marketing a broad variety of products in the EU or exporting those products outside the EU, and it will require them to undertake due diligence in order to comply with the new rules. Companies will need to ensure that they carry out the relevant due diligence and submit the statements to authorities before they market products impacted by the new Regulation. For product manufacturers, this likely will involve more in-depth quality control with their suppliers. This is part of a broader trend we are seeing of the EU adopting rules that push companies to do more due diligence and have a better handle on their supply chains. For example, similar requirements are included in the upcoming EU Batteries Regulation, the upcoming ban on products made with forced labour and the Corporate Sustainability Due Diligence Directive.
Where can I find it?
The EU Council posted the text of the provisional agreement it reached with the Parliament in December.
What are our clients asking about?
“According to the last update, the EU Commission wants to prohibit Triman logo.
- Deadline France now has two months to address the concerns raised by the Commission. Otherwise, the Commission may decide to send a reasoned opinion to France. Do you know when is the exact deadline for France? What is the date?
- Location of Triman logo prohibition The Triman logo can be placed on product, manual and packaging. In case Triman logo is prohibited, does it concern only on product or also Triman logo can’t be placed on packaging and on manuals?”
Answer by Michelle Walsh
The EU Commission sent France a “letter of formal notice” on 15 February 2023. This is a request for further information to address the EU Commission’s concerns raised on the implementation of the Triman logo waste sorting instructions.
The concerns raised in the Notice are “the imposition of national-specific labelling requirements risks undermining the principle of free movement of goods and can lead to counterproductive environmental effects. Such measures can also lead to increased material needs for additional labelling and additional waste produced due to larger than necessary sizes of the packaging.” Also, France did not notify the EU Commission of the draft proposal of the Triman law which is required under EU law.
France had officially 2 months to reply to this notice (so until 15 April 2023) and address the concerns raised.
Failure to do so, or if the EU Commission concludes that France has failed to fulfil its obligations under EU law will result in the Commission issuing a “reasoned opinion”. This is the next step in the formal procedure. The reasoned opinion is a formal request to comply with EU law and it will specify the timeframe for corrective measures to be taken by France. This is also generally 2 months. If France still doesn’t comply, the Commission may decide to refer the matter to the Court of Justice.
At this stage it is impossible to know how this will impact companies. This will depend on any corrective measures to be taken by France. For the time being, the Triman logo and sorting information remains in force and this infringement notice does not suspend its’ application.
Further information on the official procedure for non-compliance to EU law can be found below which will give you an indication of the timeframe involved:
If the EU country concerned fails to communicate measures that fully transpose the provisions of directives, or doesn’t rectify the suspected violation of EU law, the Commission may launch a formal infringement procedure. The procedure follows a number of steps laid out in the EU treaties, each ending with a formal decision:
- The Commission sends a letter of formal notice requesting further information to the country concerned, which must send a detailed reply within a specified period, usually 2 months.
- If the Commission concludes that the country is failing to fulfil its obligations under EU law, it may send a reasoned opinion: a formal request to comply with EU law. It explains why the Commission considers that the country is breaching EU law. It also requests that the country inform the Commission of the measures taken, within a specified period, usually 2 months.
- If the country still doesn’t comply, the Commission may decide to refer the matter to the Court of Justice. Most cases are settled before being referred to the court.
- If an EU country fails to communicate measures that implement the provisions of a directive in time, the Commission may ask the court to impose penalties.
- If the court finds that a country has breached EU law, the national authorities must take action to comply with the Court judgment. https://commission.europa.eu/law/law-making-process/applying-eu-law/infringement-procedure_en
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